Phase 2 N=289 Randomized Double-blind Treatment

Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT01276223 ↗

Enrolled (actual)

289

Serious AEs

0.4%

Results posted

Mar 2013

Primary outcome: Primary: Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks — 78.3; 76.8; -1.1; -1.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Difluprednate 0.05% ophthalmic emulsion (Drug); Difluprednate vehicle (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks	78.3; 76.8; -1.1; -1.7; -4.4; -4.2	—

Summary

The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Eligibility Criteria

Inclusion Criteria

Normal subjects:

No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.

Dry eye patients:

At least a 6 month history of dry eye.
Non-contact lens wearer.
Uses artificial tears.
Experiences persistent ocular discomfort.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.
History of glaucoma or ocular hypertension
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01276223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.